ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in
Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™,
to generate first in human data, and to refine surgical technique of the device.
Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal
cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures
took place over the course of one week. Subjects had in person follow-up appointments at 1
and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will
end in May 2018.

American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive
methods in gynecological surgery to ensure increased benefits to the patient and reduce
potential hospitalization costs.
Laparoscopic hysterectomy has become the standard approach in gynecological benign
disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different
sutures, techniques and approaches, which is one of the challenges of this surgery. Data is
limited on potential impact of different sutures, techniques and approaches for vaginal cuff
closure on female sexual function in relation to vaginal length.
Various studies in the literature evaluated different approaches (abdominal, vaginal,
laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different
techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures
like operation time, cuff healing, complications, cost effectiveness, etc. were usually
measured. However, there is no prospective randomized clinical study in the literature that
compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual
function in relation to vaginal length.

Objective: To compare the occurrence and intensity of pelvic pain as well as patient
satisfaction and quality of life after total laparoscopic and laparoscopic supracervical
hysterectomy.
Design: Prospective randomised trial.
Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic
pain following TLH compared with following LSH.
Null hypothesis 2: There is no significant difference in patient satisfaction and quality of
life following TLH compared with following LSH.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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